Document Detail

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Bisoprolol Fumarate.
MedLine Citation:
PMID:  24382794     Owner:  NLM     Status:  Publisher    
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing bisoprolol as the sole active pharmaceutical ingredient (API) are reviewed. Bisoprolol is classified as a Class I API according to the current Biopharmaceutics Classification System (BCS). In addition to the BCS class, its therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability problems are taken into consideration. Qualitative compositions of IR tablet dosage forms of bisoprolol with a marketing authorization (MA) in ICH (International Conference on Harmonisation) countries are tabulated. It was inferred that these tablets had been demonstrated to be bioequivalent to the innovator product. No reports of failure to meet BE standards have been made in the open literature. On the basis of all these pieces of evidence, a biowaiver can currently be recommended for bisoprolol fumarate IR dosage forms if (1) the test product contains only excipients that are well known, and used in normal amounts, for example, those tabulated for products with MA in ICH countries and (2) both the test and comparator dosage form are very rapidly dissolving, or, rapidly dissolving with similarity of the dissolution profiles demonstrated at pH 1.2, 4.5, and 6.8. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci.
Naseem A Charoo; Areeg A A Shamsher; Lai Y Lian; Bertil Abrahamsson; Rodrigo Cristofoletti; D W Groot; Sabine Kopp; Peter Langguth; James Polli; Vinod P Shah; Jennifer Dressman
Related Documents :
6195944 - Use of immunofluorescence, gram's staining, histologic examination, and seroagglutinati...
21060704 - A five-year-old boy with marked hypergastrinemia associated with h. pylori infection.
19764094 - A brazilian experience of the self transglutaminase-based test for celiac disease case ...
16757144 - The clinical applications and accuracy of 2 rapid near-patient tests in detecting helic...
24925844 - Influence de l'environnement pre-imaginal et precoce dans le choix du site de nidificat...
9122334 - Suicides and the lunar cycle.
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-12-30
Journal Detail:
Title:  Journal of pharmaceutical sciences     Volume:  -     ISSN:  1520-6017     ISO Abbreviation:  J Pharm Sci     Publication Date:  2013 Dec 
Date Detail:
Created Date:  2014-1-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  2985195R     Medline TA:  J Pharm Sci     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  TCF2/HNF-1beta mutations: 3 cases of fetal severe pancreatic agenesis or hypoplasia and multicystic ...
Next Document:  NAD(P)H-Independent Asymmetric C?C Bond Reduction Catalyzed by Ene Reductases by Using Artificial Co...